P-CARE K80G- triamcinolone acetonide, povidone-iodine, isopropyl alcohol kit

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

から入手可能:

RX PHARMA-PACK, INC.

INN（国際名）:

POVIDONE-IODINE

構図:

IODINE 10 mg in 1 mL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection and Kenalog-80 Injection (triamcinolone acetonide injectable suspension, USP) are indicated for intramuscular use as follows: Allergic states : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital  adrenal hyperplasia

製品概要:

Kenalog® -40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL. Kenalog® -80 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 80 mg triamcinolone acetonide per mL. Bristol-Myers Squibb Company Princeton, NJ 08543 USA 1374114A0 Revised: April 2019 Aerosol can: Pain Ease 3.9 fl. oz. in Medium Stream P/N 0386-0008-03 Pain Ease 1.0 fl. oz. in Medium Stream P/N 0386-0008-04 Pain Ease 3.9 fl. oz. in Mist P/N 0386-0008-02 Pain Ease 1.0 fl. oz. in Mist P/N 0386-0008-01 Manufactured by: Gebauer Company Cleveland, OH 44128 1-800-321-9348 www.Gebauer.com ©2018 Gebauer Company

認証ステータス:

New Drug Application

製品の特徴

P-CARE K80G- TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE, ISOPROPYL
ALCOHOL
RX PHARMA-PACK, INC.
----------
P-CARE K80G
KENALOG-40 INJECTION - TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION
KENALOG -40 INJECTION
(TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP)
E.R. SQUIBB & SONS, L.L.C
NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRA-ARTICULAR USE ONLY
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR
INTRATHECAL USE
DESCRIPTION
Kenalog
-40 Injection and Kenalog
-80 Injection (triamcinolone acetonide injectable suspension, USP)
are a synthetic glucocorticoid corticosteroid with anti-inflammatory
action. THESE FORMULATIONS
ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE
FORMULATIONS ARE NOT FOR INTRADERMAL INJECTION.
Kenalog
-40 Injection: Each mL of the sterile aqueous suspension provides 40
mg triamcinolone
acetonide, with 0.66% sodium chloride for isotonicity, .99% (w/v)
benzyl alcohol as a preservative,
0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium
hydroxide or hydrochloric
acid may be present to adjust pH to 5.0 to 7.5. At the time of
manufacture, the air in the container is
replaced by nitrogen.
Kenalog
-80 Injection: Each mL of the sterile aqueous suspension provides 80
mg triamcinolone
acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v)
benzyl alcohol as a preservative,
0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium
hydroxide or hydrochloric
acid may be present to adjust pH to 5.0 to 7.5. At the time of
manufacture, the air in the container is
replaced by nitrogen.
The chemical name for triamcinolone acetonide is 9-Fluoro-11β
16α,17,21-tetrahydroxypregna-1,4-
diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural
formula is:
®
®
®
®
®
KENALOG -4 0 STRUCTURAL FORMULA
Triamcinolone acetonide occurs as a white to cream-colored,
crystalline powder having not more than a
slight odor and is practically insoluble in water and very soluble in
alcohol.
CLINICAL PHARMACOLOGY
Glucocor